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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04873583




Registration number
NCT04873583
Ethics application status
Date submitted
15/04/2021
Date registered
5/05/2021
Date last updated
8/07/2024

Titles & IDs
Public title
High Dose Steroids in Children With Stroke
Scientific title
High Dose Steroids in Children With Stroke and Unilateral Focal Arteriopathy: A Multicentre Randomized Controlled Trial PASTA (Paediatric Arteriopathy Steroid Aspirin) Trial
Secondary ID [1] 0 0
2021-005571-39
Secondary ID [2] 0 0
1473_PASTA
Universal Trial Number (UTN)
Trial acronym
PASTA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Methylprednisolone
Treatment: Drugs - Prednisolone

Experimental: Steroids + Standard of care - Standard of care (including aspirin) and intravenous steroids, followed by oral tapering.

No intervention: Standard of care - Standard of care (including aspirin)


Treatment: Drugs: Methylprednisolone
At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day (max. 1000 mg/dose)

Treatment: Drugs: Prednisolone
Intravenous treatment will be immediately followed by oral tapering with Prednisolone.

Oral Prednisolone, 2 weeks (week 1 and 2) Dose: 1 mg/kg/day (max 40 mg/day) Oral Prednisolone, 2 weeks (week 3 and 4) Dose: 0.5 mg/kg/day (max 20 mg/day)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Focal Cerebral Arteriopathy Severity Score (FCASS) from baseline
Timepoint [1] 0 0
1 month (30 days)
Secondary outcome [1] 0 0
Functional impairment outcome measured by Pediatric Stroke Outcome Measure (PSOM)
Timepoint [1] 0 0
1, 3, 6 and 12 months
Secondary outcome [2] 0 0
Recovery assessed by Recovery and Recurrence Questionnaire (RRQ)
Timepoint [2] 0 0
1, 3, 6, and 12 months
Secondary outcome [3] 0 0
Degree of disability or dependence by modified Rankin Scale (mRS)
Timepoint [3] 0 0
1, 3, 6, and 12 months
Secondary outcome [4] 0 0
Clinical outcome by Vineland adaptive behavior scale (VABS)
Timepoint [4] 0 0
6 and 12 months
Secondary outcome [5] 0 0
Change in FCASS (Focal Cerebral Arteriopathy Severity Score) from baseline
Timepoint [5] 0 0
6 months
Secondary outcome [6] 0 0
Volume of stroke
Timepoint [6] 0 0
baseline, 1, 3 (if imaging is available) and 6 months
Secondary outcome [7] 0 0
Residual vasculopathy
Timepoint [7] 0 0
6 months
Secondary outcome [8] 0 0
Stroke recurrence after index stroke
Timepoint [8] 0 0
1, 6 and 12 months
Secondary outcome [9] 0 0
Stroke recurrence after index stroke in relation to the initial degree of vessel stenosis
Timepoint [9] 0 0
6 and 12 months
Secondary outcome [10] 0 0
Stroke Quality of Life Measure (PSQLM)
Timepoint [10] 0 0
12 month
Secondary outcome [11] 0 0
Preschool Wechsler Intelligence Scale for Children (WISC V) / Wechsler Preschool and Primary Scale of Intelligence (WIPPSI IV)
Timepoint [11] 0 0
12 month
Secondary outcome [12] 0 0
Delis-Kaplan Executive Function System (D-KEFS)
Timepoint [12] 0 0
12 month
Secondary outcome [13] 0 0
Continuous performance task (CPT-III)
Timepoint [13] 0 0
12 month

Eligibility
Key inclusion criteria
1. Informed consent of the legal representative of the trial participant documented by signature
2. Age > 6 months & < 18 years at time of stroke
3. Randomisation possible within 48 hours of diagnosis and maximum 96 hours after stroke onset
4. Unilateral arteriopathy according to the following criteria:

* Newly acquired neurologic deficits
* Specific neuroimaging (MRA) features of either

* unilateral stenosis, or
* unilateral vessel irregularities within the Central Nervous System (CNS)
5. Unless otherwise defined in the national addendum: Female participants age = 13: Negative pregnancy test (blood or urine)
Minimum age
6 Months
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous stroke
2. Known syndromal disorders, as e.g. Trisomy 21, Neurofibromatosis type 1
3. Known genetic vasculopathies as e.g. posterior fossa anomalies, hemangioma, arterial anomalies, cardiac anomalies and eye anomalies syndrome (PHACES), actin alpha 2 (ACTA II)
4. Moyamoya or sickle cell disease
5. Small vessel cerebral vasculitis (primary CNS vasculitis)
6. Bilateral arteriopathy
7. Arterial dissection(s)
8. Evidence of underlying systemic disorders, as e.g. lupus, rheumatoid problems
9. Secondary CNS angiitis due to infections (meningitis, endocarditis, borreliosis), or generalised angiitis due to rheumatic or other autoimmune problems
10. Progressive large to medium childhood primary angiitis of the CNS (cPACNS ) with 2 of the following 3 criteria:

1. pre-existing progressive neurocognitive dysfunction
2. bilateral MRI lesions/vessel involvement
3. small vessel arterial stenosis
11. On steroid treatment at disease onset
12. Contraindication to steroid treatment as e.g. a congenital or acquired immunodeficiency
13. Inability to follow the procedures of the study, e.g. due to language problems
14. Participation in another interventional study within the 30 days preceding the indication stroke and during the present study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Sydney Childrens Hospital Randwick - Randwick
Recruitment hospital [2] 0 0
Sydney Childrens Hospital Network - Westmead
Recruitment hospital [3] 0 0
Queensland Childrens Hospital - South Brisbane
Recruitment hospital [4] 0 0
Melbourne Childrens Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
France
State/province [2] 0 0
Alsace
Country [3] 0 0
France
State/province [3] 0 0
Auvergne-Rhône-Alpes
Country [4] 0 0
France
State/province [4] 0 0
Ile De France
Country [5] 0 0
France
State/province [5] 0 0
Provence-Alpes-Côte d'Azur
Country [6] 0 0
France
State/province [6] 0 0
Lille
Country [7] 0 0
Germany
State/province [7] 0 0
Baden-Württemberg
Country [8] 0 0
Germany
State/province [8] 0 0
Baden-Wüttemberg
Country [9] 0 0
Germany
State/province [9] 0 0
Bayern
Country [10] 0 0
Germany
State/province [10] 0 0
Nordrhein-Westfahlen
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Switzerland
State/province [12] 0 0
Graubünden
Country [13] 0 0
Switzerland
State/province [13] 0 0
Ticino
Country [14] 0 0
Switzerland
State/province [14] 0 0
Valais
Country [15] 0 0
Switzerland
State/province [15] 0 0
Vaud
Country [16] 0 0
Switzerland
State/province [16] 0 0
Basel
Country [17] 0 0
Switzerland
State/province [17] 0 0
Bern
Country [18] 0 0
Switzerland
State/province [18] 0 0
Geneva
Country [19] 0 0
Switzerland
State/province [19] 0 0
Luzern
Country [20] 0 0
Switzerland
State/province [20] 0 0
Saint Gallen
Country [21] 0 0
Switzerland
State/province [21] 0 0
Zürich
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Cambridgeshire
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Hampshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Lancashire
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Tyne And Wear
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Other
Name
Insel Gruppe AG, University Hospital Bern
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Bern
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial deals with focal cerebral arteriopathy and childhood stroke, a rare but devastating condition.

Focal cerebral arteriopathy (FCA) is an inflammatory vessel wall disease provoked by infection and there is increasing evidence that inflammatory processes play a crucial role in childhood stroke, influencing the outcome of the disease.

Analysis of existing data suggests that outcomes are improved and that there is less stroke recurrence in children treated with steroids to reduce the acute inflammatory processes. This clinical trial will be conducted in over 20 hospitals in several countries in order to investigate this.

Participants will be randomly separated into two groups. The first group will be treated with standard of care (including aspirin) combined with high dose steroids. The second group will be treated with standard of care (including aspirin) but without steroid treatment.

The objective is to investigate if children treated with a combination of high dose steroid and aspirin will have a better and quicker recovery of FCA, better clinical functional outcome, and less recurrence compared to children treated with aspirin alone.

This project has been identified by international pediatric stroke experts as the most important topic for a clinical trial in the field and is as well one of the most important research priorities identified by parents. The study results will also provide insight into the evolution of inflammatory vessel disease.
Trial website
https://clinicaltrials.gov/study/NCT04873583
Trial related presentations / publications
Steinlin M, O'callaghan F, Mackay MT. Planning interventional trials in childhood arterial ischaemic stroke using a Delphi consensus process. Dev Med Child Neurol. 2017 Jul;59(7):713-718. doi: 10.1111/dmcn.13393. Epub 2017 Jan 25.
Public notes

Contacts
Principal investigator
Name 0 0
Maja Steinlin, Dr. med.
Address 0 0
Bern university hospital, Inselspital Bern, Kinderklinik
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maja Steinlin, Dr. med.
Address 0 0
Country 0 0
Phone 0 0
+41 31 6329424
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04873583